AbClon, Inc.

LUND, SE / ACCESSWIRE / December 04, 2024 / Alligator Bioscience (STO:ATORX)Lund, Sweden, November 27, 2024 - Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that the Company was notified that the first patient has been dosed in a Phase 3 clinical trial with Shanghai Henlius Biotech, Inc. Alligator out-licensed HLX22/AC101 to AbClon, Inc. in October 2016. Abclon, Inc. subsequently sub-licensed AC101 for clinical development by Shanghai Henlius Biotech Inc."We are pleased to announce that Henlius Biotech has dosed the first patient in its Phase 3 international multi-centre clinical trial of HLX22/AC101, aiming to provide a new first-line treatment for HER2-positive advanced gastric/gastroesophageal junction cancer. This progress demonstrates Henlius' commitment to the HLX22/AC101 program. Also, this bodes well for Henlius' completion of the ongoing Phase 2 trial, which will trigger a milestone payment to Alligator," said Søren Bregenholt, CEO of Alligator Bioscience.For further information, please contact:Søren Bregenholt, CEOE-mail: [email protected]Phone: +46 (0) 46 540 82 00Johan Giléus, CFOE-mail: [email protected]Phone: +46 (0) 46 540 82 00About Alligator BioscienceAlligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.For more information, please visit alligatorbioscience.com.AttachmentsAlligator Announces First Patient Dosed in Shanghai Henlius Biotech, Inc. Phase 3 Clinical TrialSOURCE: Alligator Bioscience

DUBLIN--( BUSINESS WIRE )--The "B-cell Lymphoma - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This "B-cell Lymphoma- Pipeline Insight, 2024" report provides comprehensive insights about 295+ companies and 300+ pipeline drugs in B-cell Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence B-cell Lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve B-cell Lymphoma. B-cell Lymphoma Emerging Drugs Chapters This segment of the B-cell Lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. B-cell Lymphoma: Therapeutic Assessment This segment of the report provides insights about the different B-cell Lymphoma drugs segregated based on following parameters that define the scope of the report, such as: Major Players in B-cell Lymphoma There are approx. 295+ key companies which are developing the therapies for B-cell Lymphoma. The companies which have their B-cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Denovo BioPharma. The report covers 300+ products under different phases of clinical development like: Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration B-cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Subcutaneous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Monoclonal antibody Small molecule Peptide Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. B-cell Lymphoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses B-cell Lymphoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging B-cell Lymphoma drugs. B-cell Lymphoma Report Insights B-cell Lymphoma Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs B-cell Lymphoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing B-cell Lymphoma drugs? How many B-cell Lymphoma drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of B-cell Lymphoma? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the B-cell Lymphoma therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for B-cell Lymphoma and their status? What are the key designations that have been granted to the emerging drugs? Key Players Lisocabtagene maraleucel Hoffmann-La Roche Nektar Therapeutics Miltenyi Biomedicine AVM Biotechnology Lin BioScience Incyte Corporation ADC Therapeutics Genor Biopharma Beijing InnoCare Pharma Tech Co., Ltd. CARGO Therapeutics Chia Tai Tianqing Pharmaceutical Group Co., Ltd. SystImmune LIBO PHARMA Abclon BeiGene Cellectis Iovance Biotherapeutics, Inc. Guangzhou Excelmab Y-mAbs Therapeutics TG Therapeutics Sutro Biopharma AbbVie Aleta Biotherapeutics Janssen Research & Development Lantern Pharma Beijing Immunochina Medical Science and Technology Bantam Pharmaceutical Lin Bioscience SFA Therapeutics neoX Biotech March Biosciences HUTCHMED Key Products Bristol Myers Squibb Glofitamab NKTR-255 Zamtocabtagene autoleucel MB-CART20.1 AVM0703 LBS-007 Parsaclisib Loncastuximab tesirine GB-241 ICP-248 CRG-022 TQB3702 GNC-038 NM-IL-12 AT101 BGB-16673 UCART20x22 IOV-2001 EX103 CD38-SADA TG-1801 STRO-001 ABBV-319 ALETA-001 JNJ-80948543 LP-284 INS19 CAR-T Cells BTM 3566 LBS-007 SFA-001 NXD07 MB-105 HMPL A067 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/qxd94m About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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Early results from a Phase I clinical trial of AT101, a new CAR T cell therapy that uses a distinct binding mechanism to target CD19, show a 100 percent complete response (CR) rate at the higher dose levels studied in the trial. Early results from a Phase I clinical trial of AT101, a new CAR T cell therapy that uses a distinct binding mechanism to target CD19, show a 100 percent complete response (CR) rate at the higher dose levels studied in the trial, according to researchers from the University of Pennsylvania Perelman School of Medicine and Penn Medicine's Abramson Cancer Center. The findings were published today in Molecular Cancer and presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 2096). CAR T cell therapy has revolutionized treatment for many people with blood cancers who had run out of other treatment options. While some patients experience long-term responses to CAR T cell therapy, it doesn't work-or the cancer eventually returns-for others. The CD19 CAR T cell therapies that are currently approved all target CD19 through the same epitope (FMC63). To try and make CD19 CAR T cell therapy more effective for more patients, Marco Ruella, MD, an assistant professor of Hematology-Oncology and Scientific Director of the Lymphoma Program, and his research team, along with the Korean company AbClon Inc, co-developed a CAR T product (AT101), using cells originating from the same patient, that targets CD19 through a different epitope, located closer to the cell membrane, via a novel antibody (h1218). In preclinical studies, the team previously demonstrated that h1218-CART19 had decreased T cell exhaustion and improved control compared to FMC63-CART19. The Phase I first-in-human clinical trial (NCT05338931) was conducted in South Korea and enrolled 12 patients with relapsed or refractory B cell non-Hodgkin's lymphoma (NHL). The study was designed to increase the dose level of AT101 after safety was confirmed in the first six patients. After a median follow-up of 6.5 months, all six patients who received dose level 2 or higher experienced a complete response and their cancer has not relapsed. "We've learned that the way you design your CAR really matters. Designing a different CAR might drastically change the way the T cells work, potentially allowing that CAR T cell product to work where other CAR T cell products have failed," Ruella said. "We were not expecting such a drastic early difference in this study. The CART19 products that are already FDA-approved are very effective, and it's not easy to do better. While there is not a randomized trial of this product yet, the initial results seem very promising, and we look forward to moving into the planned Phase II portion of the study." The drug was found to be safe, with manageable side effects, including cytokine-release syndrome in four patients and immune-cell-related neurotoxicity syndrome in three patients. One patient experienced grade 3 sepsis that resolved; the same patient later developed fatal neutropenic septic shock outside the dose-limiting toxicity time frame. The Phase I study enrolled patients who had not previously received any other CAR19 therapy. In the Phase II expansion, the study will also include patients who have previously received CAR19 therapy.